The BATTLE Trial · BATTLE objective To demonstrate the clinical superiority of primary stenting...
Transcript of The BATTLE Trial · BATTLE objective To demonstrate the clinical superiority of primary stenting...
BATTLE RCT investigators:Y. Gouëffic, A. Sauguet, P. Desgranges, P. Feugier, E. Rosset, E. Ducasse, A. Cardon, S. Rinckenbach, J.M. Pernes, P. Commeau, P. Lermusiaux, B. Guyomarc’h,
L. Bressolette.
The BATTLE TrialComparing Bare Metal to Drug Eluting Stents for
Intermediate Length Lesions of the SFA
BATTLE ClinicalTrials.gov number, NCT02004951
PI: Pr Yann Gouëffic
DisclosureSpeaker name: Yann Gouëffic
◻ I have the following potential conflicts of interest to report:
◻ Receipt of grants/research support
Details: Abbott; Bard; Medtronic; Terumo; WL Gore
◻ Receipt of honoraria and travel support
Details: Abbott; Bard; Boston Sc; Cook; Medtronic; Perouse; Spectranetics
◻ Employment in industry
Details: /
◻ Shareholder in a healthcare company
Details: /
◻ Owner of a healthcare company
Details: /
◻ I do not have any potential conflicts of interest to report
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Previous and recent RCTs compared to POBA
Schillinger, NEJM, 2006; Laird, Circ Cardiovasc Interv, 2010; Dake,
Circ Cardiovasc Interv. 2011; Tepe, Circulation, 2015; Rosenfield
NEJM, 2015; Schroeder, Circulation, 2017
VIENNA, RESILIENT, ZILVER PTX, INPACT SFA, LEVANT 2,
ILLUMINATE…
POBA is not the standard of care anymore
BATTLE trial French multicentric randomized clinical trial comparing MISAGO vs. ZILVER PTX
for the treatment of intermediate femoropopliteal lesions(from February 2014 to September 2018)
10 centers: Clinique d'Antony (Jean-
Marc PERNES); CHU de Besançon
(Simon RINCKENBACH); CHU de
Bordeaux (Eric DUCASSE) ; CHU de
Clermont Ferrand (Eugenio ROSSET) ;
AP-HP, Hôpital Henri Mondor (Pascal
DESGRANGES) ; CHU de Lyon
(Patrick FEUGIER) ; CH de Bourgouin
(Patrick LERMUSIAUX); Clinique
Ollioules (Philippe COMMEAU) ; CHU
de Rennes (Alain CARDON) ; Clinique
Pasteur (Antoine SAUGUET); CHU de
Nantes (Yann GOUËFFIC)
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*Sponsor Nantes University Hospital
BATTLE ClinicalTrials.gov number, NCT02004951
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- Investigator initiated study
- RCT multicenter and controlled
- Sample size calculation: 186 patients
- Rigorous data collection process, independent
- Adjudication by:- Duplex ultrasound core laboratory
- Clinical events committee
- Data safety monitoring board
- Follow-up includes- 1, 6, 12, and 24-month clinical assessment
- 1, 12 and 24-month stent x-ray
- Monitoring with 100% source data verification
BATTLE trial protocolSponsor Nantes University Hospital - BATTLE ClinicalTrials.gov number, NCT02004951
BATTLE objective
To demonstrate the clinical superiority of primary stenting using Zilver PTX
stent system versus bare metal self-expandable stenting in the treatment of
intermediate length femoropopliteal lesions in patients with symptomatic
peripheral arterial disease (Rutherford 2-5).
BATTLE primary endpoint
Freedom from in-stent restenosis @ 1 year
Defined by restenosis of >50% and by a peak systolic velocity index >2.4 at the target lesion. Assessment by an independent core laboratory
Study devices(BATTLE interim analysis)
- Flexible stent design
- Moderate radial force
- RX system
- One hand operation
- Accurate deployment
Misago® (Terumo)
- Self expendable nitinol stent with a polymer-free paclitaxel coating
- Paclitaxel, a cytotoxic drug- Over-the-wire system
Zilver PTX® (Cook)
Main inclusion criteria
-Rutherford stages 2-5
- De novo atherosclerotic lesions (stenosis and/or occlusion) of the SFA, the proximal popliteal artery
(P1), or both
- Target lesion has a length ≥2-cm and ≤14-cm
- RVD 4 to 7-mm
Main exclusion criteria
-Asymptomatic lesion
-Restenosis
-No atheromatous disease
Key eligible criteria(BATTLE 6-month outcomes interim analysis)
186 were included5 not randomized
-2 have exclusion criteria-3 were doubloon error
181 underwent randomization
Group B (90)
85 underwent assigned
intervention
Group A (91)
84 underwent assigned
intervention
82 completed 6-month follow-up
80 completed6-month follow-up
Demographic data (BATTLE 6-month outcomes interim analysis)
Group A (N= 84) Group B (N=85)
Age (y) 67±12 70±12
Sex ♂, n (%) 61 (73) 61 (72)
Smoking, n (%) 28 (33) 20 (24)
Hypertension (%) 51 (61) 58 (68)
Diabetes mellitus (%) 22 (26) 40 (47)
Dyslipidemia (%) 60 (71) 54 (63)
Renal failure (%) 6 (7) 8 (9)
CAD (%) 34 (40) 27 (32)
Statines (%) 60(71) 57(67)
Antiplatelet drug (%) 73(87) 71(84)
ACE inhibitors (%) 26(31) 18(21)
Claudication: group A: 82% / group B: 80%
Baseline angiographic data(BATTLE 6-month outcomes interim analysis)
Group A (N= 84)
Group B (N=85)
Mean lesion length (cm) 70 ± 40 65 ± 35
Reference vessel diameter (mm)
5.7 ± 0.6 5.8 ± 0.7
# of patent run-off vessel…1…2…3
13 (15)12(14)59 (70)
11 (13)27 (32)47 (55)
Procedural characteristics(BATTLE 6-month outcomes interim analysis)
Group A (n= 84) Group B (n=85)
Pre-dilatation performed (%) 70 (83) 68 (80)
Number of implanted stents (%)…1…2…3Stents localisation…Proximal SFA…Mid SFA…Distal SFA…P1
10167 (80)17 (20)
0(0)
14544415
116*56 (65)27 (32)
2(2)
10564510
Mean stent length (per stent)Mean stent length (per patient)Diameter 6
91±41 (40-150)90,7±38,2 (40-150)
74
72±26 (40-150)70,4±22,1 (40-105)
86
Post dilatation performed 72(86) 79 (93)
Concomitant ipsilateral endo repair (%)
16(19) 19(22)
Intraoperative complications (%) 8(10) 5(6)
Cumulative safety data @ 6 months(BATTLE 6-month outcomes interim analysis)
Group A Group B
Death (%) 1 1
Rehospitalization (%) 12 (2) 12(6)
Major amputation (%) 0 0
Reintervention of the target lesion (%) 2 1
Clinical outcomes @ 6 months(BATTLE 6-month outcomes interim analysis)
CLI: 18% / 20% CLI: 1% / 2%
0% 0%
24%20%
17% 19%
9%13%
65% 61%
1% 3%
14%13%
0% 1%4% 7%1% 1%
0%
20%
40%
60%
80%
100%
120%
1 2 1 2
5
4
3
2
1
0
Baseline 6months
Rutherfordstage
Ru
the
rfo
rd s
tage
s
Group A Group BGroup B Group A
Baseline 6 months
Cumulative morphological data @ 1 month(BATTLE 6-month outcomes interim analysis)
In-stent restenosis: N=8
Group A: n=6
Group B: n=2
Thrombosis: N=13
Group A: n=6
Group B: n=7
*In-stent restenosis is defined by restenosis > 50% and by a peak systolic velocity(PSV) ratio > 2.4 at the lesion site.
Hemodynamic outcomes @ 6 month(BATTLE interim analysis)
ABI at baseline:- Group A0.71 ± 0,21- Group B 0,68 ± 0,18
ABI at M6:- Group A0,96 ± 0,18- Group B 0,90 ± 0,17
Group A Group B
BATTLE take home message(6 months outcomes interim analysis)
- BATTLE enrolment is completed: the assigned
number of patients has been reached (N=186)
- Follow-up and monitoring are undergoing
- Primary endpoint results will be released this year
- BATTLE trial completion date (2 years FU) :
September 2018
BATTLE RCT investigators:Y. Gouëffic, A. Sauguet, P. Desgranges, P. Feugier, E. Rosset, E. Ducasse, A. Cardon, S. Rinckenbach, J.M. Pernes, P. Commeau, P. Lermusiaux, B. Guyomarc’h,
L. Bressolette.
The BATTLE TrialComparing Bare Metal to Drug Eluting Stents for
Intermediate Length Lesions of the SFA
BATTLE ClinicalTrials.gov number, NCT02004951
PI: Pr Yann Gouëffic